Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.
- Define non-compliance
- Determine who is responsible for corrective action planning
- Recognize components of corrective action planning
- Identify examples of corrective action plans for different levels of noncompliance (case scenarios)
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
- Quality Assurance Personnel
Gary B. Freeman, M.S.
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